Archived - CellCept (mycophenolate mofetil) - Advisories, Warnings and Recalls for the Public

Starting date:

October 13, 2006

Posting date:

October 25, 2006

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000401

This is duplicated text of a letter from Hoffmann-La Roche Limited.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on CellCept^® (mycophenolate mofetil)

October 13, 2006

Subject: Higher than expected rate of rejection in heart transplant patients treated with an investigational immunuosuppressant combination of sirolimus, CellCept^® (mycophenolate mofetil), and corticosteroids.

Hoffmann-La Roche Limited, in consultation with Health Canada, would like to inform Canadian heart transplant patients of important safety information regarding an increased rate of rejection in heart transplant patients using a specific combination of anti-rejection drugs in a clinical trial which was conducted to determine if this combination therapy would provide better kidney function following transplantation. The study was stopped because of a higher rate of acute rejection in heart transplant patients who were switched at 12 weeks post-transplantation from the usual standard therapy, which includes CellCept, cyclosporine or tacrolimus as well as corticosteroids, to the investigational combination of sirolimus, CellCept, and corticosteroids.

There were no Canadian patients enrolled in this clinical trial.

It is important to note that these results apply only to the specific combination of drugs studied in this clinical trial. In Canada, CellCept is authorized for the prevention of organ rejection in patients receiving kidney, heart or liver transplants. CellCept should be used in combination with other anti-rejection drugs such as cyclosporine and corticosteroids.

Patients taking CellCept and any other prescribed anti-rejection medications should not discontinue or change their medication without discussion with their transplant physician.

Hoffmann-La Roche Limited has sent a letter to transplant physicians informing them of this new safety information. A copy of the Healthcare Professional letter and this communication are available on the Health Canada website.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or other serious or unexpected adverse reactions in patients receiving CellCept should be reported to Hoffmann-La Roche Limited or Health Canada at the following addresses:

Hoffmann-La Roche Limited

Drug Safety Department

2455 Meadowpine Boulevard

Mississauga, Ontario, L5N 6L7

Call toll free at: 1-888-762-4388

Fax at: 905-542-5864

Email to: mississauga.drug_safety@roche.com

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

Health Canada

Address Locator: 0701C

Ottawa, Ontario, K1A 0K9

Tel: (613) 957-0337

Fax: (613) 957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:

Tel: 866 234-2345

Fax: 866 678-6789

cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

E-mail: MHPD_DPSC@hc-sc.gc.ca

Tel: (613) 954-6522

Fax: (613) 952-7738

Sincerely,

Original signed by

Lorenzo Biondi,

Vice President, Medical and Regulatory Affairs

Hoffmann-La Roche Limited